VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Stopped early · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia (CLL)

In brief

Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. This study had two parts, a dose escalation part and a dose expansion part.

Key facts

Study ID

NCT03400176

Run by

Novartis Pharmaceuticals

People needed

39

Starts

2018-04-09

Expected to finish

2023-09-29

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of CLL per the WHO classification
• At least 18 years of age
• Lack of a complete response after receiving ibrutinib for > 1 year OR presence of known ibrutinib resistance mutation
• Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)

You may not qualify if…

• Known history of HIV
• Active hepatitis B or C infection
• Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.

Where it is running

• University of California San Diego - Moores Cancer Center — La Jolla, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Ohio ST Compr Cancer Ctr James Hosp — Columbus, Ohio, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• Uni of Utah Huntsman Cancer Inst — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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